I think documentation of each potential risk found and measures to deal with it, whether it be avoidance or mitigation. It’s important that if a risk it found, there’s no way for it to appear frequently once the product reaches…   Read more»

I think the distinction is important because they happen at different stages, and thus must be managed differently. Hazards are managed by prevention to stop the danger from ever happening in the first place. That’s why regular maintenance is usually…   Read more»

I think a good way to decided what levels of residual risk is acceptable is to create a quantifiable way to measure it, instead of leaving it up to opinions. The scale would make it clearer for how often the…   Read more»

The failure of the DePuy hip implant is probably due to not enough diversity in the testing population. Real world patients can vary widely in weight, height bone density and levels of physical activity can affect an implant’s effectiveness over…   Read more»

A good CM manufacturer should validate machines and have a maintenance plan, and also provide full documentation for proof that the process works the same way every time. The document should have test plans, results and checks if the equipment…   Read more»

I agree that multiple review meeting should be made during a medical device’s lifecycle. Deciding on how many meetings are happening should be governed by what goals must be met before being able to move on to the next step….   Read more»

I would probably say that this is more a case by case approach. For devices or features that are high risk, verifications and validation should be strictly separate to keep results trustworthy. But for lower risk features, you can afford…   Read more»

How about instead you design the DHF around making it easier for the reviewer to read it in mind, rather than the regular documents? Starting with a one-page index of the most critical user needs and for each one, creating…   Read more»

Design control can actually be better for innovation, as it acts as a filter that would let ideas that wouldn’t pass regulation be rejected immediately, and the constraints would force for more unique innovations that still manage to be within…   Read more»

An important guideline for medical companies is ensuring data integrity in clinical research. This is where the ALCOA+ principle (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available) comes in, and what CRAs look for regarding documents and…   Read more»

Along with everything else, everyone has mentioned, biomedical engineers also help with making sure that what a clinical trial measures actually matters. The study has to show specific results that show whether a device worked or not. Engineers help translate…   Read more»

While GCP regulations can slow development, the FDA has several programs in place that see to expedite the wait time. In class when learning about the specific pathways that medical products can take, we also learned about Investigational Device Exemption…   Read more»

You can make medical device marketing more ethical and accurate by doing a human-factors testing, something similar to testing that’s done during device design. Before releasing ads about the product to the public, companies could first show them to a…   Read more»

I think one way to keep medical device marketing effective while still being ethical is implementing something similar to a traceability matrix into the marketing process. This would require every statement used in marketing to be required to be connected…   Read more»

For marketing products in general, knowing who your audience is can determine how to optimize your marketing strategy towards that audience. For medical devices specifically, that audience would typically be the hospital’s internal evaluation group rather than just physicians. Most…   Read more»

Physicians branching out into entrepreneurship can have positive effects on healthcare. However, access can also be an issue with newly developed technologies. Not every community will equally benefit from those innovations. Telehealth, for example, requires that patients have reliable access…   Read more»

I think that the corporate veil is an important protection that allows people to take on the risk of starting a company or investing in one in the first place. Without that protection, the uncertainty of a business surviving or…   Read more»

Obviously, AI is already being heavily researched and expanded on, with many companies finding way on how to seamlessly implement it into their system. AI can indeed help handle routine pats, like checking if training is up-to-date, finding documents or…   Read more»

It’s true that having things be more measurable makes it easier to provide clear results. One way I see of preventing that can be to create a checklist between QA and QC that explains what standards QA expects, and QC…   Read more»